The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are: * How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease? * How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake? The neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake. Participants in the intervention group will: * receive one 30 min treatment session daily for 12 months * receive either T-PEMF or sham treatment for the first 6 months * receive active T-PEMF treatment the last 6 months * visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
30 min daily stimulation with transcranial pulsed electromagnetic fields (50 Hz)
30 min daily the participants are using/wearing the T-PEMF device but no stimulation occurs
Odense University Hospital
Odense, Denmark
RECRUITINGUniversity of Southern Denmark
Odense, Denmark
RECRUITINGSit-to-stand
Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Tremor intensity
Postural tremor intensity assessed by accelerometer
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Rate of force development
Isometric rate of force development assessed by handgrip and knee extension
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS will be reported as total score (0-260, higher scores indicate greater disease severity) and motor score (part III, 0-132, higher scores indicate greater disease severity).
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Cerebrospinal fluid biomarkers
Concentration of growth factors, cytokines and cytoskeletal proteins with special emphasis on erythropoietin (EPO), vascular endothelial growth factor (VEGF), brain-derived neutrophic factor (BDNF), glia cell derived neutrophilic factor (GDNF), Glucagon Like Peptide 1 (GLP1), interleukins and neurofilament light chain (NfL).
Time frame: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.
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